Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-05-30

Brief Summary

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A case-control study will evaluate the clinical utility of the Congo Red test GV-005 in following women with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum period

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Detailed Description

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A case-control study (n=150) will evaluate the clinical utility of the Congo Red test GV-005 in following women with a clinical diagnosis of preeclampsia and clinically healthy women in the postpartum period. Women with preeclampsia (n=100) (cases) and clinically healthy women (n=50)(controls) who are hospitalized postpartum will be recruited for the trial. All women will be asked to provide a urine sample. Samples will be collected daily during a woman's hospitalization. The Congo Red test GV-005 and a standard urine dipstick proteinuria test will be performed by a lab technician within 72 hours of sample collection. The purpose of this research is to evaluate progression of urine congophilia postpartum by following patients diagnosed with preeclampsia and clinically healthy women.

Conditions

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Preeclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CLINICALLY CONFIRMED PREECLAMPSIA

Women clinically diagnosed with preeclampsia (severe, mild or superimposed) during pregnancy will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.

Congo Red test GV-005

Intervention Type DEVICE

Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine.

CLINICALLY HEALTHY

Women with a delivery of a healthy normal baby at term (induction of labor or an elective Caesarean Section) will provide a urine sample in the postpartum period to determine the presence or absence of proteinuria using the Congo Red test GV-005.

Congo Red test GV-005

Intervention Type DEVICE

Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine.

Interventions

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Congo Red test GV-005

Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Postpartum
* Clinical diagnosis of preeclampsia (severe, mild or superimposed) including eclampsia (n=100) OR Clinically healthy (n=50)
* Eligible to consent for research
* Agree to comply with study procedures
* Able to give informed consent